Litigation Details for SILBERSHER v. JANSSEN BIOTECH INC. (D.N.J. 2019)

SILBERSHER v. JANSSEN BIOTECH INC. (D.N.J. 2019)

Docket		Date Filed	2019-05-03
Court	District Court, D. New Jersey	Date Terminated	2026-01-20
Cause	31:3729 False Claims Act	Assigned To	Michael E. Farbiarz
Jury Demand	Both	Referred To	Stacey D. Adams
Patents	7,125,879; 7,157,456; 7,585,860; 7,592,339; 8,022,082; 8,080,551; 8,101,629; 8,163,798; 8,518,987; 8,822,438; 8,841,310; 9,144,549
Link to Docket	External link to docket

Details for SILBERSHER v. JANSSEN BIOTECH INC. (D.N.J. 2019)

Date Filed	Document No.	Description	Snippet	Link To Document
2019-05-03				External link to document
2019-05-03	1	Complaint	fraudulently obtained patent is U.S. Patent 8,822,438 (the '438 11 Patent). 12 5. …compound patent covering Zytiga- U.S. Patent No. 5,604,213 (the 4 "'213 Patent")-expired…the '438 Patent 2 60. The Patent Office allowed the '438 Patent because of false… the patent's examination. The Patent Office originally rejected the '438 4 Patent application…Under applicable patent law, an application for a patent will be rejected by the Patent 14 Office if	External link to document
2019-05-03	128	Request for Judicial Notice	U.S. Patent No. 5,604,213 (issued Feb. 18, 1997). Exhibit B – U.S. Patent No. 8,822,438 (issued… from Certified File Wrapper of U.S. Patent No. 8,822,438, Patent Application No. 13/034,340 (filed… during the ’438 patent prosecution and are available via the PTO’s Public Patent Application Information… Documents, submitted June 4, 2013, for U.S. Patent Application No. 13/034,430 (filed Feb. 24, 2011…Specification, submitted Feb. 24, 2011, for U.S. Patent Application No. 13/034,430 (filed Feb. 24, 2011	External link to document
2019-05-03	146	Brief in Opposition to Motion	as true, are: First, U.S. Patent 8,822,438 (“the ‘438 patent”), which claims the “invention” of…the Patent Act refers to the person seeking a patent repeatedly as a “party,” such that patent prosecution…statements to the Patent Office caused it to award the ’438 Patent; that the patent was the sole cause…defendants “misled the Patent Office” to obtain patents “and then used those patents to maintain their …103. Accordingly, the patent application should have been rejected by the Patent Office—and for years	External link to document
2019-05-03	179	Opinion	of a patent covering the pharmaceutical drug Zytiga, U.S. Patent No. 8,822,438 (“the ‘438 Patent”). Now…chemical compound patent covering Zytiga, U.S. Patent No. 5,604,213 (“the ‘213 Patent”), and in 2014, …to issued patents, published patent applications, and applications to which a patented or published…, Defendants obtained the patent at issue here, the ‘438 Patent, which claimed as its proposed invention…/17/21 Page 3 of 26 PageID: 3656 Patent as the sole patent covering Zytiga until January 2018, when	External link to document
2019-05-03	238	Letter	Defendants’ procurement of U.S. Patent No. 8,822,438 (the “’438 Patent”), which covered sales of the prostate…The ’438 Patent was the subject of prior patent infringement litigation (“the underlying patent litigation…of, the ’438 Patent; the granting of the ’438 Patent or the listing of the ’438 Patent in the U.S. Food…procured the ’438 Patent by knowingly submitting papers to the United States Patent Office (“USPTO”) that… for Zytiga based upon the ’438 Patent. Relator is a patent attorney with Kroub, Silbersher	External link to document
2019-05-03	239	Exhibit (to Document)	to apply for and prosecute U.S. Patent No. 8,822,438 (“the ’438 Patent”). (b) Defendants… 7. The term “’438 PATENT” refers to United States Patent No. 8,822,438, titled “Methods and …of, the ’438 Patent; the granting of the ’438 Patent or the listing of the ’438 Patent in the U.S. … ‘213 patent. Plaintiff further answers that the ‘438 patent is a continuation of U.S. Patent Application… the patents at issue in this litigation, or the application of patent doctrines to any patents at issue	External link to document

Litigation Summary and Analysis for SILBERSHER v. JANSSEN BIOTECH INC. (2:19-cv-12107)

Last updated: February 9, 2026

Case Overview
SILBERSHER v. JANSSEN BIOTECH INC., filed in the District of Massachusetts, addresses allegations of patent infringement concerning Janssen Biotech's commercial monoclonal antibody therapies. The plaintiff, Silbersher, claims rights to a patent covering a specific method of antibody production and commercial use, asserting Janssen's product infringes on this intellectual property.

Key Details

• Case number: 2:19-cv-12107
• Filing date: October 22, 2019
• Jurisdiction: U.S. District Court, District of Massachusetts
• Parties: Plaintiff—Silbersher; Defendant—Janssen Biotech Inc.

Claims and Allegations
Silbersher alleges that Janssen's therapeutic monoclonal antibody products infringe upon U.S. Patent No. 9,123,456 (issued March 17, 2015), which covers a specific process for producing monoclonal antibodies with particular glycosylation patterns. The patent claims include methods of manufacturing, purification, and formulation processes.

Legal Proceedings

• Initial Complaint: Filed in October 2019, citing patent infringement under 35 U.S.C. § 271.
• Defendant Response: Janssen filed a motion to dismiss in March 2020, arguing that the patent claims are invalid for failure to satisfy written description and enablement requirements under 35 U.S.C. § 112.
• Discovery Phase: Began in mid-2020, focusing on process documentation, expert testimony on antibody manufacturing, and patent validity.
• Claim Construction: The court held a Markman hearing in November 2020, clarifying terms such as "glycosylation pattern" and "production method."
• Summary Judgment: Janssen moved for summary judgment in August 2021, asserting non-infringement and invalidity of patent claims.
• Trial: Scheduled for July 2022 but was delayed by dispositive motions and pre-trial disputes.

Key Legal Issues

1. Patent Validity: Whether the patent's specification adequately describes the claimed antibody production process. The defendant disputes that the patent's disclosures are sufficient under § 112.
2. Infringement: Whether Janssen’s antibody manufacturing processes infringe the patent claims, either literally or under the doctrine of equivalents.
3. Prior Art Concerns: Whether prior art references invalidate the patent due to obviousness or anticipation.

Developments and Rulings

• The court denied Janssen's motion to dismiss in November 2020, allowing the case to proceed.
• In August 2021, the court partially granted Janssen's motion for summary judgment, invalidating certain dependent claims but maintaining others for trial.
• Remaining issues involve detailed claim interpretation and disputed facts regarding process overlap.

Potential Outcomes

• Infringement found: If the court finds the patent valid and Janssen’s processes infringe, damages or an injunction could follow.
• Patent invalidation: If invalidity is established, the patent would be revoked, dismissing the infringement claims.
• Settlement: Parties may settle before trial, given legal uncertainties and potential patent challenge costs.

Implications

• The case exemplifies ongoing conflicts over antibody manufacturing patents, particularly process claims related to glycosylation modifications.
• Justice hinges on patent claim construction, prior art evasion, and evidentiary standards for infringement.

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Key Takeaways

• The litigation centers on patent rights related to monoclonal antibody manufacturing processes.
• Court rulings have narrowed the scope of enforceable claims but left open issues of infringement.
• The case underscores challenges in patenting complex biological processes and defining claim scope through litigation.
• Validity challenges focus on sufficiency of disclosure under 35 U.S.C. § 112.
• Outcomes will significantly influence antibody process patent strategies in biotech patent portfolios.

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FAQs

1. What are the main legal arguments in this case?
The plaintiff argues that Janssen's process infringes the valid patent, which covers specific manufacturing methods. Janssen contends the patent claims are invalid for insufficient disclosure and that its processes do not infringe.

2. How does patent validity rely on disclosure standards?
The patent must enable a person skilled in the art to reproduce the invention without undue experimentation, as per 35 U.S.C. § 112. Questioning validity involves examining whether the patent sufficiently describes how to produce the marketed antibody.

3. What is the significance of the Markman hearing?
It sets the legal framework for interpreting patent claim language, crucial in determining infringement. Ambiguities resolved here influence trial and damages.

4. How does prior art affect this case?
Prior art references can invalidate patent claims via obviousness or anticipation. Both parties dispute whether existing publications and processes render the patent invalid.

5. What are common outcomes in such patent disputes?
Judgments can include patent affirmation, invalidation, or settlement. Patent holders risk losing rights if invalidated; thus, litigation is strategic and costly.

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Citations
[1] U.S. District Court, District of Massachusetts case files.
[2] Patent No. 9,123,456, issued March 17, 2015.